We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antineoplaston Therapy in Treating Patients With Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00003498
Recruitment Status : Terminated (Slow accrual)
First Posted : January 27, 2003
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Burzynski Research Institute

Brief Summary:

Current therapies for Non-Hodgkin's Lymphoma provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Non-Hodgkin's Lymphoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Non-Hodgkin's Lymphoma.


Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: Antineoplaston therapy (Atengenal + Astugenal) Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with non-Hodgkin's lymphoma who have failed high-dose chemotherapy and bone marrow transplantation.
  • Describe the response to, tolerance to, and side effects of this regimen in these patients.

Non-Hodgkin's Lymphoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in patients with Non-Hodgkin's Lymphoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in patients with Non-Hodgkin's Lymphoma.
  • To determine objective response, tumor size is measured utilizing physical examination, radiologic studies, and bone marrow biopsies as necessary, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma
Actual Study Start Date : December 5, 1996
Primary Completion Date : November 28, 2000
Study Completion Date : November 28, 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Antineoplaston therapy
Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Drug: Antineoplaston therapy (Atengenal + Astugenal)

Patients with Non-Hodgkin's Lymphoma will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Other Name: A10 (Atengenal); AS2-1 (Astugenal)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven non-Hodgkin's disease that has failed both prior high-dose chemotherapy and bone marrow transplantation

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 2 months

Hematopoietic:

  • WBC greater than 2,000/mm^3
  • Platelet count greater than 20,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.5 mg/dL

Renal:

  • Creatinine no greater than 2.5 mg/dL
  • No history of renal conditions that contraindicate high dosages of sodium

Cardiovascular:

  • No hypertension
  • No history of congestive heart failure
  • No history of other cardiovascular conditions that contraindicate high dosages of sodium

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 4 weeks after study participation
  • No serious active infections

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered
  • No concurrent immunomodulatory agents (e.g., interferon or interleukin-2)

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • At least 4 weeks since prior corticosteroids
  • No concurrent corticosteroids

Radiotherapy:

  • At least 8 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • No prior antineoplaston therapy
  • No other concurrent antineoplastic agents
  • No concurrent antibiotics, antifungals, or antivirals

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003498


Locations
United States, Texas
Burzynski Clinic
Houston, Texas, United States, 77055-6330
Sponsors and Collaborators
Burzynski Research Institute
Investigators
Principal Investigator: Stanislaw R. Burzynski, MD, PhD Burzynski Research Institute

Additional Information:
Responsible Party: Burzynski Research Institute
ClinicalTrials.gov Identifier: NCT00003498     History of Changes
Other Study ID Numbers: CDR0000066537
BC-LY-3 ( Other Identifier: Burzynski Research Institute )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Burzynski Research Institute:
Non Hodgkin Lymphoma Recurrent
Non Hodgkin Lymphoma Refractory

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases